On March 31, 2025, the United Kingdom issued the final draft of the Cosmetics (Chemical Restrictions) Regulation 2025 to impose restrictions on the use of Methyl salicylate hydroxybenzoate (CAS No. 119-36-8). This substance is classified as a Category CMR (2) substance under the EU Regulation (EC) No. 1272/2008 on classification, labeling, and packaging. As a result, the item for Methyl Salicyla..

On February 3, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced new guidance on Digital Mental Health Technologies (DMHT) due to the increasing use of mental health apps, AI-based assessments, virtual reality therapies, and other digital mental health technologies. This new guidance is aimed at manufacturers.  The guidance document helps manufacturers identify th..

On December 20, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) emphasized the importance of Post-Market Surveillance (PMS) by announcing the final PMS Statutory Instrument (PMS SI) as the Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024 (SI 2024 No. 1368). While most of the PMS SI requirements align with EU PMS requirements, new requir..

On October, 24, 2024, the Office for Product Safety and Standards (OPSS) requested all stakeholders, including the cosmetics industry, academia, consumer associations, and others, to submit scientific information related to the safety assessment of the following cosmetic ingredients:1.     Prostaglandins and prostaglandin analogues2.     Alpha and beta-arbutin3.     Vitamin A All scientific data..

The UK Office for Product Safety and Standards (OPSS) has requested the disposal of all cosmetics containing the prohibited ingredient "Lilial" (Butylephenyl methylpropional) on October 14, 2024. This ingredient is known to be harmful to the reproductive system and was added to Annex 2 of the Toys and Cosmetics (Prohibited Substances) Regulations in 2022, prohibiting the sale of products contain..

UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a consultation to seek views from interested stakeholders on proposals to update its statutory fees.  MHRA consultation on statutory fees - proposals on ongoing cost recovery are as follows. 1) Proposal 1 The MHRA proposes to increase the statutory fees shown in Annex B to ensure c..

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices. Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK..

Summary イギリスのEU脱退により、ECでななくMHRA（Medicines and Healthcare products Regulatory Agency）に基づき 医療機器が規制されております。 MHRAは患者及び公共の安全のために協力な規制の最低及び国際的なパートナーシップを通じてPandemic期間中に、 その基盤を固めました。 MHRAの規制フレームの要点は下記5項目となります。 ・Strengthening MHRA power to act to keep patients safe ・Marking the UK a focus for innovation, the best place to develop and introduce innovative madical devices ・Addressing health inequalities an..

MHRA(Medicines and Heaithcare products regulatory Agency)から2022年7月28日付で、イギリス医療機器登録ガイダンスをアップデートしました。 新しいガイダンスに含まれる内容は、コロナテスト装備の承認部分です。 イギリスにコロナウイルステスト装備を輸出及び流通する予定の業者及び担当者は、UKHSA（UK's Health Security Agency）から承認完了後にイギリス市場に進出可能です。 MHRAでは、コロナウイルステスト装備UKHSAのClearanceを進行するまでは、製品登録を承認しない予定です。 詳しい内容は下記リンクご参照くださいませ。 Register medical devices to place on the market – GOV.UK (www.gov.uk) 医療機器認証と関連し気になる点がござ..

Am 24. Aug. 2021 aktualisierte BEIS das Guidance, um die CE-Kennzeichnung auf dem Markt in Great Britain bis zum 31. Dez. 2022 verwendet werden zu können. Dadurch wurde die Zeit für die Vorbereitung auf die Verpflichtung der UKCA-Bestimmungen verlängert, aber BEIS empfiehlt jedoch, die Verwendung der UKCA-Kennzeichnung so bald wie möglich zu beginnen. Das aktualisierte Guidance von BEIS können S..